Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However, no studies have determined whether treating insomnia decreases the risk of suicidality. We have new data indicating that (1) the link between insomnia and suicidal ideation holds true in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal, depressed insomniacs may reduce suicide risk in a multi-site clinical trial.

Health related quality of life (HRQOL)subscales of the Basis-32 (the daily living and role functioning (DLRF) subscale and relationship to self and others subscale (RSO). It will be assessed at each visit.

The participants will wear an actigraph on their non-dominant wrist for the duration of the randomized treatment. Estimates of sleep latency, wake after sleep onset, and total sleep time will be obtained from the medium sensitivity setting at 30-second epochs. We have previously reported that actigraphy tracks polysomnography reasonably-well in depressed insomniacs. Actigraphic data will also be archived for potential future additional data analysis (functional analysis).

Overview of the Need for and Management of a Collaborative Application: The sample sizes required to satisfy the Aims are relatively large, necessitating the pooled recruiting resources of 3 sites. Georgia Regents University (GRU) will serve both as the coordinating/data management site, as well as a recruiting site, with Duke and Wisconsin as recruiting sites. Project management will be coordinated through an Executive Committee of site principal investigators, under the supervision of a Data and Safety Monitoring Board.

Impact on the Field: This application has the potential to change providers' practice in the approach to treating insomnia in depressed patients with mild-moderate suicidal ideation. It may also reveal the mechanisms whereby insomnia increases the risk for suicidal ideation and behavior, and begin to examine whether there is an actigraphic "signature" for reductions in suicidal ideation. When these lessons are applied to the clinical world, they can be applied with low cost.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Persons 18-65 years of age

Persons with confirmed DSM-IV diagnosis of MDE by SCID

Persons with Research Diagnostic Criteria diagnosis of insomnia

Persons free of all psychotropic medications for one week before baseline assessment, except that prior FLX treatment will require 4 weeks of abstinence, and MAOIs will require 2 weeks of abstinence.

Persons with a self-reported history of napping > 2 times per week (as these are associated with sleep apnea and periodic limb movement disorder in depressed insomniacs)

Persons who might be harmed by exposure to hypnotics, including pregnant women and patients with respiratory conditions

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01689909